Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name gown, surgical
510(k) Number K061308
Device Name TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
Applicant
CARDINAL HEALTH 200, INC.
1500 WAUKEGAN ROAD
MCGAW PARK,  IL  60685
Applicant Contact LAVENIA FORD
Correspondent
CARDINAL HEALTH 200, INC.
1500 WAUKEGAN ROAD
MCGAW PARK,  IL  60685
Correspondent Contact LAVENIA FORD
Regulation Number878.4040
Classification Product Code
FYA  
Date Received05/10/2006
Decision Date 06/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-